A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

Overview

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics sub-study.

Full Title of Study: “An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

  • Other: Continue-smoking
    • Ad-libitum use of subjects’ usual brand combustible cigarette
  • Other: myblu Tobacco Chill 2.5%
    • Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 2.5% nicotine
  • Other: myblu Tobacco Chill 4.0%
    • Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 4.0% nicotine
  • Other: myblu Honeymoon 2.5%
    • Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
  • Other: myblu Honeymoon 4.0%
    • Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine

Arms, Groups and Cohorts

  • Active Comparator: Continue-smoking
    • The subject’s usual brand of combustible cigarette
  • Experimental: myblu Tobacco Chill 2.5%
    • myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 2.5% nicotine
  • Experimental: myblu Tobacco Chill 4.0%
    • myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 4.0% nicotine
  • Experimental: myblu Honeymoon 2.5%
    • myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 2.5% nicotine
  • Experimental: myblu Honeymoon 4.0%
    • myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 4.0% nicotine

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of carboxyhemoglobin in blood
    • Time Frame: 56 days
    • Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood
  • Amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in urine in 24 hours
    • Time Frame: 56 days
    • Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL – a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
  • Amount of 3-hydroxypropylmercapturic acid in urine in 24 hours
    • Time Frame: 56 days
    • Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA – a biomarker of exposure to acrolein) excreted in urine in 24-hours
  • Amount of s-phenyl mercapturic acid in urine in 24 hours
    • Time Frame: 56 days
    • Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA – a biomarker of exposure to benzene) excreted in urine in 24-hours

Secondary Measures

  • Amount of nicotine in urine in 24 hours
    • Time Frame: 56 days
    • The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
  • Level of white blood cells
    • Time Frame: 56 days
    • The change from baseline in the level of white blood cells, which is a biomarker of potential harm
  • Subjective Measure: Nicotine Withdrawal Symptoms
    • Time Frame: 56 days
    • Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
  • Maximum nicotine concentration in blood
    • Time Frame: 180 minutes following the start of product use (11 measurements over the period)
    • The maximum nicotine concentration in blood (Cmax)

Participating in This Clinical Trial

Inclusion Criteria

  • Having smoked ≥5 manufactured combustible cigarettes per day for at least one year
  • Exhaled carbon monoxide level of >10 ppm at screening
  • Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Exclusion Criteria

  • Relevant illness history
  • Relevant medication use
  • Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
  • Allergy to propylene glycol or glycerin
  • Use of nicotine-containing products other than manufactured cigarettes
  • Use of prescription smoking cessation treatments
  • Smokers who draw smoke into their mouth and throat but do not inhale
  • Intent or desire to stop smoking
  • Female subjects who are pregnant, lactating, or intend to become pregnant

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fontem Ventures BV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Julie Saathoff, +1 402 437 4829, julie.saathoff@celerion.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.